Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension

Autor: Ashrafian, Hutan, Beam, Andrew L, Collins, Gary S, Darzi, Ara, Deeks, Jonathan J, ElZarrad, M Khair, Espinoza, Cyrus, Esteva, Andre, Faes, Livia, Ferrante di Ruffano, Lavinia, Fletcher, John, Golub, Robert, Harvey, Hugh, Haug, Charlotte, Holmes, Christopher, Jonas, Adrian, Keane, Pearse A, Kelly, Christopher J, Lee, Aaron Y, Lee, Cecilia S, Manna, Elaine, Matcham, James, McCradden, Melissa, Moher, David, Monteiro, Joao, Mulrow, Cynthia, Oakden-Rayner, Luke, Paltoo, Dina, Panico, Maria Beatrice, Price, Gary, Rowley, Samuel, Savage, Richard, Sarkar, Rupa, Vollmer, Sebastian J, Yau, Christopher, Cruz Rivera, Samantha, Liu, Xiaoxuan, Chan, An-Wen, Denniston, Alastair K ^*, Calvert, Melanie J

Publikováno v: In The Lancet Digital Health October 2020 2(10):e549-e560

Advancing an agile regulatory ecosystem to respond to the rapid development of innovative technologies.

Autor: ElZarrad, M. Khair¹ (AUTHOR) mohammed.elzarrad@fda.hhs.gov, Lee, Aaron Y.² (AUTHOR), Purcell, Rose¹ (AUTHOR), Steele, Scott J.^1,3 (AUTHOR)

Publikováno v: CTS: Clinical & Translational Science. Jun2022, Vol. 15 Issue 6, p1332-1339. 8p.

Reporting guideline for the early-stage clinical evaluation of decision support systems driven by artificial intelligence

Autor: Vasey, Baptiste, Nagendran, Myura, Campbell, Bruce, Clifton, David A, Collins, Gary S., Denaxas, Spiros, Denniston, Alastair K., Faes, Livia, Geerts, Bart, Ibrahim, Mudathir, Liu, Xiaoxuan, Mateen, Bilal A., Mathur, Piyush, Mccradden, Melissa D., Morgan, Lauren, Ordish, Johan, Rogers, Campbell, Saria, Suchi, Ting, Daniel S. W., Watkinson, Peter, Weber, Wim, Wheatstone, Peter, Mcculloch, Peter, Lee, Aaron Y., Fraser, Alan G., Connell, Ali, Vira, Alykhan, Esteva, Andre, Althouse, Andrew D., Beam, Andrew L., de Hond, Anne, Boulesteix, Anne-Laure, Bradlow, Anthony, Ercole, Ari, Paez, Arsenio, Tsanas, Athanasios, Kirby, Barry, Glocker, Ben, Velardo, Carmelo, Park, Chang Min, Hehakaya, Charisma, Baber, Chris, Paton, Chris, Johner, Christian, Kelly, Christopher J., Vincent, Christopher J., Yau, Christopher, Mcgenity, Clare, Gatsonis, Constantine, Faivre-Finn, Corinne, Simon, Crispin, Sent, Danielle, Bzdok, Danilo, Treanor, Darren, Clifton, David A., Wong, David C., Steiner, David F., Higgins, David, Benson, Dawn, O’Regan, Declan P., Gunasekaran, Dinesh V., Danks, Dominic, Neri, Emanuele, Kyrimi, Evangelia, Schwendicke, Falk, Magrabi, Farah, Ives, Frances, Rademakers, Frank E., Fowler, George E., Frau, Giuseppe, Hogg, H. D. Jeffry, Marcus, Hani J., Chan, Heang-Ping, Xiang, Henry, Mcintyre, Hugh F., Harvey, Hugh, Kim, Hyungjin, Habli, Ibrahim, Fackler, James C., Shaw, James, Higham, Janet, Wohlgemut, Jared M., Chong, Jaron, Bibault, Jean-Emmanuel, Cohen, Jérémie F., Kers, Jesper, Morley, Jessica, Krois, Joachim, Monteiro, Joao, Horovitz, Joel, Fletcher, John, Taylor, Jonathan, Yoon, Jung Hyun, Singh, Karandeep, Moons, Karel G. M., Karpathakis, Kassandra, Catchpole, Ken, Hood, Kerenza, Balaskas, Konstantinos, Kamnitsas, Konstantinos, Militello, Laura, Wynants, Laure, Oakden-Rayner, Lauren, Lovat, Laurence B., Smits, Luc J. M., Hinske, Ludwig C., Elzarrad, M. Khair, van Smeden, Maarten, Giavina-Bianchi, Mara, Daley, Mark, Sendak, Mark P., Sujan, Mark, Rovers, Maroeska, Decamp, Matthew, Woodward, Matthew, Komorowski, Matthieu, Marsden, Max, Mackintosh, Maxine, Abramoff, Michael D., de la Hoz, Miguel Ángel Armengol, Hambidge, Neale, Daly, Neil, Peek, Niels, Redfern, Oliver, Ahmad, Omer F., Bossuyt, Patrick M., Keane, Pearse A., Ferreira, Pedro N. P., Schnell-Inderst, Petra, Mascagni, Pietro, Dasgupta, Prokar, Guan, Pujun, Barnett, Rachel, Kader, Rawen, Chopra, Reena, Mann, Ritse M., Sarkar, Rupa, Mäenpää, Saana M., Finlayson, Samuel G., Vollam, Sarah, Vollmer, Sebastian J., Park, Seong Ho, Laher, Shakir, Joshi, Shalmali, van der Meijden, Siri L., Shelmerdine, Susan C., Tan, Tien-En, Stocker, Tom J. W., Giannini, Valentina, Madai, Vince I., Newcombe, Virginia, Wei Yan, Ng, Rogers, Wendy A., Ogallo, William, Park, Yoonyoung, Perkins, Zane B.

Publikováno v: Nature Medicine, 28, 5, pp. 924-933
Nature Medicine, 28, 924-933
the DECIDE-AI expert group 2022, ' Reporting guideline for the early-stage clinical evaluation of decision support systems driven by artificial intelligence : DECIDE-AI ', Nature Medicine, vol. 28, no. 5, pp. 924-933 . https://doi.org/10.1038/s41591-022-01772-9

A growing number of artificial intelligence (AI)-based clinical decision support systems are showing promising performance in preclinical, in silico evaluation, but few have yet demonstrated real benefit to patient care. Early-stage clinical evaluati

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::494201e4e9c4ed8004edc11458c67580
https://doi.org/10.1038/s41591-022-01772-9

Landscape Analysis of the Application of Artificial Intelligence and Machine Learning in Regulatory Submissions for Drug Development From 2016 to 2021.

Autor: Liu, Qi, Huang, Ruihao, Hsieh, Julie, Zhu, Hao, Tiwari, Mo, Liu, Guansheng, Jean, Daphney, ElZarrad, M. Khair, Fakhouri, Tala, Berman, Steven, Dunn, Billy, Diamond, Matthew C., Huang, Shiew‐Mei

Publikováno v: Clinical Pharmacology & Therapeutics; Apr2023, Vol. 113 Issue 4, p771-774, 4p

List of contributors

Autor: Ahn, Joseph C., Anand, Shankara, Arnaout, O., Bandyopadhyay, Anuja, Bartholomew, Erin, Bates, David W., Bender, Sarah M.L., Bhullar, Puneet K., Bhutani, Tina, Boaro, A., Boyer, Edward W., Brown, Ethan D.L., Carreiro, Stephanie, Chahla, Jorge, Chandran, Viji Pulikkel, Cheng, Ching-Yu, Cheung, Carol Y., Choudhary, Anirudh, Choudhury, Avishek, Chung, Mimi, Ciurtin, Coziana, Comfere, Nneka I., Corriveau-Lecavalier, Nick, Côté, Mélina, del Alamo, Diego, Dias, Roger D., Dönnes, Pierre, Duong, Dat, Ebnali, Mahdi, El Sherbini, Adham, ElZarrad, M. Khair, Fakhouri, Tala H., Fakhoury, Marc, Fein, Joshua A., Fischer, Uwe M., Glicksberg, Benjamin S., Goldstein, Cathy, Gonem, Sherif, Green, Darren V.S., Gupta, Raghav, Hakimi, Marwa, Halamka, John D., Han, Christina S., Hannah-Shmouni, Fady, Harrer, Stefan, Hazime, Ali Amer, Howard, Michael A., Hui, Herbert Y.H., Ildardashty, Alexander, J.F. Shaikh, Hashim, Jeliazkov, Jeliazko R., Jones, David T., Juhn, Young J., Jury, Elizabeth C., Kandaswamy, Swaminathan, Kang, Yanna, Kann, Benjamin H., Kaplin, Scott, Karpiak, Joel, Kassir, Elias, Kaur, Harsimran, Khan, Sohil, Khatib, Reem, Kherabi, Yousra, Knake, Lindsey A., Krittanawong, Chayakrit, Kuhn, Veronica C., Kunze, Kyle, Lamarche, Benoît, Laplante, Simon, Lehmann, Lisa Soleymani, Li, Dawei, Liao, Wilson, Likitlersuang, Jirapat, Liu, Qi, Madani, Amin, Malik, Momin M., Mann, Matthias, Masood, Sameer, Mathur, Piyush, McManus, Sean, Menard, Jeffrey, Mivalt, Filip, Murphree, Dennis, Myers, Thomas G., Narayan, Sanjiv M., Natarajan, Vivek, Pandav, Krunal, Parwani, Anil V., Pedraza Bermeo, Adriana Marcela, Peiffer-Smadja, Nathan, Peng, Junjie, Peng, Lily, Peters, Margot S., Petrick, Nicholas, Polce, Evan, Poojari, Pooja Gopal, Price, W. Nicholson, II, Raghavan, Lavanya, Rajan, Asha K., Ran, An Ran, Rangu, Sowmith, Rashid, Muhammed, Reddy, Charitha D., Rider, Nicholas L., Rigatti, Marc, Rivers, Michael, Robinson, George, Rogers, Albert J., Rogerson, Colin M., Ryu, Euijung, Sahiner, Berkman, Sarnaik, Kunaal, Shafi, Saba, Shah, Vijay H., Shapovalov, Maxim V., Sharma, Samin K, Shekhar, Skand, Shin, Harold, Shouval, Roni, Smith, Kenneth, Sokumbi, Olayemi, Solomon, Benjamin D., Somani, Sulaiman S., Sternke, Matt C., Strauss, Maximillian T., Syrowatka, Ania, Tang, W. H. Wilson, Teven, Chad M., Tewari, Ashutosh Kumar, Thunga, Girish, Urena, Estefania, Verma, Ashish, Vietas, Jay, Waikel, Rebekah L., Wi, Chung-Il, Winter, Meredith C., Wong, Melissa S., Wong, Tien Yin, Wu, Chao-Ping, Yeroushalmi, Samuel, Zenati, Marco A., Zeng, Wen-Feng, Zheng, Yingfeng

Publikováno v: In Artificial Intelligence in Clinical Practice 2024:xv-xxi